Effects of Mechanical Insufflation-Exsufflation in Preventing Respiratory Failure After Extubation (MIEICU)
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|ClinicalTrials.gov Identifier: NCT01424202|
Recruitment Status : Completed
First Posted : August 26, 2011
Last Update Posted : August 26, 2011
Weaning protocols that include the use of noninvasive ventilation (NIV), decreases the incidence of re-intubation and ICU length of stay. However, the role of NIV in post-extubation failure is still not clear. Impaired airway clearance is associated with NIV failure. Mechanical Insufflation-Exsufflation (MI-E) is an assisted coughing technique that has been proven to be very effective in patients under NIV.
In this study the investigators assess the efficacy of MI-E as part of a protocol for patients that develop respiratory failure after extubation.
|Condition or disease||Intervention/treatment||Phase|
|Post-extubation Failure Persistent Weaning Failure Secretion Encumbrance Weak Cough Ventilatory Failure||Device: Mechanical Insufflation Exsufflation||Not Applicable|
Patients under mechanical ventilation (MV) for more than 48 hours with specific inclusion criteria, who successfully tolerated an spontaneous breathing trial (SBT) were randomly allocated before extubation, either for (A) conventional extubation protocol (control group) or (B) MI-E extubation protocol (study group). Re-intubation rates, ICU length of stay and NIV failure rates were analyzed.
Inclusion of MI-E in post-extubation failure may reduce re-intubation rates with consequent reduction in post-extubation ICU length of stay. This technique seems to be efficient in improving the efficacy of NIV in this patient population.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||92 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Effects of Mechanical Insufflation-Exsufflation in Preventing Respiratory Failure After Extubation|
|Study Start Date :||September 2008|
|Actual Primary Completion Date :||June 2010|
|Actual Study Completion Date :||October 2010|
Experimental: Group B
Patients received (post-extubation) standard medical treatment (SMT), including NIV in case of specific indications plus daily sessions of mechanical in-exsufflation (MI-E).
Device: Mechanical Insufflation Exsufflation
After passing the SBT and randomized to group B, before extubation, all patients were submitted to a treatment of MI-E (3 sessions) through the endotracheal tube with pressures set at 40 cm H2O for insufflation and -40 cm H2O for exsufflation pressure. An insufflation/exsufflation time ratio of 3secs/2 secs and a pause of 3 sec between each cycle was used. Eight cycles were applied in every session with an abdominal thrust timed to the exsufflation cycle.
On top of the standard medical therapy, during the first 48 hours post extubation, each patient received 3 daily treatments by means of a light-weight, elastic oronasal mask. Treatments (3 sessions each) were divided between morning, afternoon and night, making a total of 9 daily sessions.
The daily treatment frequency and its outcomes were recorded in a diary by the nursing staff. All MI-E treatments were administered by a trained respiratory therapist, ICU physician or nurse.
No Intervention: Group A
Patients received (post-extubation) standard medical treatment (SMT), including NIV in case of specific indications.
- re-intubation rates [ Time Frame: 48 hours ]
- NIV failure rates [ Time Frame: 48 hours ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01424202
|Intensive Care and Emergency Department;, Faculty of Medicine, University Hospital of S. João|
|Porto, Portugal, 4200-319|